Pharmacokinetics of Anidulafungin on Intensive Care Unit (ICU)

Sponsor

University Medical Center Groningen (Other)

Overall Status

Completed

CT.gov ID

NCT01047267

Collaborator

(none)

Enrollment

Location

Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The objective of this study is to determine whether pharmacokinetic parameters of anidulafungin correlate with disease severity and plasma protein levels in critically ill patients.

Condition or Disease	Intervention/Treatment	Phase
Invasive Candidiasis Critically Ill

Detailed Description

One of the risk factors for mortality of patients with candidemia is inadequate antifungal therapy. The first days in the intensive care unit (ICU), patients are unstable and it can be questioned whether therapeutic levels of anidulafungin are reached after a standard loading scheme. At this moment there are several clues that the PK of anidulafungin in critically ill patients is different, but an overall picture is lacking.

For the investigation of the correlation of the pharmacokinetics of anidulafungin and the disease severity a full pharmacokinetic profile will be obtained. Predictive scoring systems will be used to assess disease severity.

Study Design

Study Type:

Observational

Actual Enrollment :

20 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

Pharmacokinetics of Anidulafungin in Critically Ill Patients With Invasive Candidiasis

Study Start Date :

Jun 1, 2010

Actual Primary Completion Date :

Nov 1, 2011

Actual Study Completion Date :

Dec 1, 2011

Outcome Measures

Primary Outcome Measures

To investigate the correlation of pharmacokinetic parameters of anidulafungin with markers for disease severity - either disease severity scores or parameters (singly, or combined) for inflammation or organ function - and plasma protein levels. [3 days]

Secondary Outcome Measures

Time (in days) to culture conversion [max 28 days]
Response to treatment at day 28 [28 days]
Mortality at day 28 due to fungal infection and overall mortality at 28 days [28 days]
AUC/MIC ratio, time above MIC [max 28 days]
Composing a pharmacokinetic model of anidulafungin in critically ill patients [max 28 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

treatment with anidulafungin
at least 18 years of age
invasive candidiasis
admitted to an intensive care unit

Exclusion Criteria:

allergic to anidulafungin or its excipients
contra-indication stated in SPC
neutropenia

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Medical Center Groningen	Groningen		Netherlands	9713GZ

Sponsors and Collaborators

University Medical Center Groningen

Investigators

Study Chair: JWC Alffenaar, PharmD, PhD, University Medical Center Groningen
Principal Investigator: MJP van Wanrooy, PharmD, University Medical Center Groningen